Effects of a parental support intervention for parents in prison on child-parent relationship and criminal attitude—The For Our Children’s Sake pragmatic controlled study

Background Children of incarcerated parents run a high risk for poor health and marginalisation across development where positive parenting comprises an essential protective factor. The For Our Children’s Sake (FOCS) intervention is delivered with incarcerated parents in Sweden to support parenting and healthy child development. This study aimed to explore the effects of the FOCS intervention on relationship quality between parent and child, parent criminal attitude and interest in treatment, while investigating intervention fidelity. Methods The non-randomised non-blinded pragmatic controlled study was carried out during 2019–2020 in 15 prisons with 91 parents throughout Sweden. Group allocation was based on the set operation planning at each prison. Prisons delivering FOCS during the study period were recruited to the intervention group, whereas prisons delivering FOCS later were recruited to the control group. Outcomes were measured through parent-report at baseline September-December 2019 (T0), after intervention (T1) in January-April 2020, and at three-months follow-up in April-July in 2020 (T2). The primary outcome was relationship quality between incarcerated parent and child and secondary outcomes were criminal attitude, interest in other treatment programmes, and child-parent contact. Fidelity to intervention delivery was monitored through objectively rated audio recorded sessions by researchers, and by group-leader-reported logs. Group differences on outcome over time and at each time point were explored using mixed-model regression with repeated measures with an intention-to-treat approach and per protocol. Results The intention-to-treat analysis showed favourable intervention effects over time for relationship quality, explained by a higher intervention group score at T2. An intervention effect was found for parental interest in other prison-delivered treatments at T2. The analysis per protocol found similar but stronger effects on the relationship quality and an additional intervention effect over time for criminal attitude, also explained by a significant group difference at T2. The effect on treatment interest did not reach statistical significance in the analysis per protocol. Group leaders reported that all sessions had been performed and the objective ratings of fidelity rendered overall acceptable delivery of the intervention. Conclusions The FOCS intervention had beneficial effects on relationship quality, and outcomes related to criminality which suggests that a parenting intervention for incarcerated parents has the potential to influence both parenting outcomes and outcomes related to a criminal lifestyle. Future studies should investigate intervention effectiveness on long-term outcomes related to both child health and parental recidivism. Further development of intervention components is suggested with the hypothesis to increase intervention effectiveness. Trial registration ClinicalTrials.gov: No. NCT04101799, prospectively registered on September 24, 2019, Identifier: https://clinicaltrials.gov/ct2/show/NCT04101799, The authors confirm that all ongoing and related trials for this intervention are registered.


Introduction
Background 2 Scientific background and explanation of rationale Theories used in designing behavioral interventions

Methods
Participants 3 Eligibility criteria for participants, including criteria at different levels in recruitment/sampling plan (e.g., cities, clinics, subjects) Method of recruitment (e.g., referral, self-selection), including the sampling method if a systematic sampling plan was implemented Recruitment setting Settings and locations where the data were collected Interventions 4 Details of the interventions intended for each study condition and how and when they were actually administered, specifically including: Unit of assignment (the unit being assigned to study condition, e.g., individual, group, community) Method used to assign units to study conditions, including details of any restriction (e.g., blocking, stratification, minimization) Inclusion of aspects employed to help minimize potential bias induced due to non-randomization (e.g., matching) Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to study condition assignment; if so, statement regarding how the blinding was accomplished and how it was assessed.
Unit of Analysis 10 Description of the smallest unit that is being analyzed to assess intervention effects (e.g., individual, group, or community) If the unit of analysis differs from the unit of assignment, the analytical method used to account for this (e.g., adjusting the standard error estimates by the design effect or using multilevel analysis) Statistical Methods

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Statistical methods used to compare study groups for primary methods outcome(s), including complex methods of correlated data Statistical methods used for additional analyses, such as a subgroup analyses and adjusted analysis Methods for imputing missing data, if used Statistical software or programs used

Participant flow 12
Flow of participants through each stage of the study: enrollment, assignment, allocation, and intervention exposure, follow-up, analysis (a diagram is strongly recommended) o Enrollment: the numbers of participants screened for eligibility, found to be eligible or not eligible, declined to be enrolled, and enrolled in the study o Assignment: the numbers of participants assigned to a study condition o Allocation and intervention exposure: the number of participants assigned to each study condition and the number of participants who received each intervention o Follow-up: the number of participants who completed the followup or did not complete the follow-up (i.e., lost to follow-up), by study condition o Analysis: the number of participants included in or excluded from the main analysis, by study condition Description of protocol deviations from study as planned, along with reasons Recruitment 13 Dates defining the periods of recruitment and follow-up Baseline Data 14 Baseline demographic and clinical characteristics of participants in each study condition Baseline characteristics for each study condition relevant to specific disease prevention research Baseline comparisons of those lost to follow-up and those retained, overall and by study condition Comparison between study population at baseline and target population of interest Baseline equivalence 15 Data on study group equivalence at baseline and statistical methods used to control for baseline differences  Numbers analyzed 16 Number of participants (denominator) included in each analysis for each study condition, particularly when the denominators change for different outcomes; statement of the results in absolute numbers when feasible Indication of whether the analysis strategy was "intention to treat" or, if not, description of how non-compliers were treated in the analyses Outcomes and estimation 17 For each primary and secondary outcome, a summary of results for each estimation study condition, and the estimated effect size and a confidence interval to indicate the precision Inclusion of null and negative findings Inclusion of results from testing pre-specified causal pathways through which the intervention was intended to operate, if any Ancillary analyses 18 Summary of other analyses performed, including subgroup or restricted analyses, indicating which are pre-specified or exploratory Adverse events 19 Summary of all important adverse events or unintended effects in each study condition (including summary measures, effect size estimates, and confidence intervals)

Interpretation 20
Interpretation of the results, taking into account study hypotheses, sources of potential bias, imprecision of measures, multiplicative analyses, and other limitations or weaknesses of the study Discussion of results taking into account the mechanism by which the intervention was intended to work (causal pathways) or alternative mechanisms or explanations Discussion of the success of and barriers to implementing the intervention, fidelity of implementation Discussion of research, programmatic, or policy implications Generalizability 21 Generalizability (external validity) of the trial findings, taking into account the study population, the characteristics of the intervention, length of follow-up, incentives, compliance rates, specific sites/settings involved in the study, and other contextual issues Overall Evidence

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General interpretation of the results in the context of current evidence and current theory